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GenDx Receives CE Mark for HLA Typing Software

NEW YORK (GenomeWeb) – Dutch genetic testing firm GenDx announced yesterday that it has received CE-IVD certification for its NGSengine software.

The software provides analysis of human leukocyte antigen (HLA) typing by next-generation sequencing on several platforms, including Illumina's MiSeq, Thermo Fisher Scientific's IonTorrent PGM, and Pacific Biosciences' PacBio RSII. It includes whole gene representation, automatic allele assignment and multi loci analysis, and simultaneous genotyping of multiple HLA loci, as well as a variety of reviewing and reporting options.

"We are excited about this very important milestone in the process of a complete CE-IVD-marked NGS workflow, from DNA amplification to HLA typing," GenDx Managing Director Wietse Mulder said in a statement. The firm said it is the first to offer CE-marked analysis software for NGS-based HLA typing.

HLA genes code for cell-surface antigen-presenting proteins and HLA typing is an important genetic analysis in assessing compatibility between donor and recipient in stem cell and solid organ transplants. HLA mismatches can result in transplant failure. HLA typing can be done with both Sanger and NGS sequencing technologies. GenDx also offers the CE-marked AlleleSeqr product line, SBTengine software platform, and SBTexcellerator reagents for Sanger sequencing-based HLA typing.

The CE-marking will "help to expand the use of NGSengine across EMEA and rest of the world in the next coming years," the company added.